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  • Design
    Regulatory Perspectives: Anatomy of a Medical Policy

    Regulatory Perspectives: Anatomy of a Medical Policy

    Health insurance is a contract between a third party payer (insurer) and an individual to help cover medical and surgical expenses. The insured party pays a premium to the health insurer for this benefit. The rights and obligations of the insured and…
    Bonnie Clothier and Simran Madhani, MCRA 03.29.19

  • Your 2019 ‘Regulatory Issues to Watch’ List

    Your 2019 ‘Regulatory Issues to Watch’ List

    In 2018, one of the most prominent themes for the medical device industry had to be change. The year marked a continued transition for a number of regulatory initiatives as well as the emergence of several new challenges. In spite of how serious some…
    Sean Fenske, Editor-in-Chief 02.13.19

  • Your EU Medical Devices Regulation (MDR) Questions, Answered

    Your EU Medical Devices Regulation (MDR) Questions, Answered

    The upcoming EU Medical Devices Regulation (MDR) changes are significant, potentially impacting device classification and the need for clinical data. It’s imperative organizations act now to meet these requirements in 2020 and beyond. Portfolio…
    Nancy Morrison, Director of Regulatory Affairs, Regulatory and Quality Solutions LLC (R&Q) 03.21.18

  • The Impact of U.S. Regulation on Medical Device Innovation

    The Impact of U.S. Regulation on Medical Device Innovation

    Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators. During World War II, antibiotics were scarce and chronic osteomyelitis and bone deficiencies such as non-unions and deformities were common.…
    Patricia Kontoudis, Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 02.12.18

  • Anika Therapeutics Appoints Vice President of Regulatory and Clinical Affairs

    Anika Therapeutics Appoints Vice President of Regulatory and Clinical Affairs

    Deep international expertise to drive the company’s global expansion.
    Business Wire 09.15.17

  • Software & Quality
    The Importance of an Integrated QMS Within Regulatory Industries

    The Importance of an Integrated QMS Within Regulatory Industries

    The life sciences market is constantly evolving, and automated quality and compliance solutions must follow suit. The ability to interact, collaborate, and coordinate across the board is key to uncovering gaps in processes and creates visibility betw…
    Emily Ysaguirre, Content Marketing Writer, VERSE Solutions 05.19.17

  • Regulatory-Viewpoint

    New Drugmaker Ethical Code May Be Relevant for Device Companies
    07.24.08